Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed. Specifically, the trial is testing a combination of nimotuzumab, chemotherapy, and radiotherapy to see how effective and safe this treatment is for patients who did not respond well to previous treatments. The goal is to improve the chances of complete tumor removal and reduce side effects.

To be eligible for the trial, participants should have a confirmed diagnosis of ESCC and should have undergone 2 to 4 cycles of initial chemotherapy or immunotherapy without a positive response. They also need to have good overall health as measured by specific blood tests and a performance status score. Participants can expect to receive a combination of treatments and will be monitored closely for their response and any side effects. This trial is currently recruiting patients aged 65 to 75, and both men and women can participate.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.
• • Cycles of induction chemo(immuno)therapy was 2-4.
• • KPS score ≥70.
• • Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;
• Exclusion Criteria:
• • Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• • At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
• • There are active infections, such as active tuberculosis and hepatitis
• • There are contraindications to targeted therapy.